A Proposal to Study the Safety and Efficacy of Psilocybe cubensis in Preclinical and Clinical Studies as a Therapeutic Alternative for Major Depressive Disorder
Journal of Psychoactive Drugs – August 18, 2023
Source: OpenAlex
Summary
Psilocybin, a natural alkaloid, offers breakthrough potential for major depressive disorder, contrasting with current antidepressants' modest effects. A comprehensive project in Medicine and Psychiatry will conduct preclinical research, assessing toxicity and characterizing *Psilocybe cubensis* via chemical synthesis and alkaloid analysis. Subsequent clinical trials in Pharmacology will evaluate safety in healthy adults, then efficacy in patients with major depressive disorder, comparing two single doses (with assisted psychotherapy, reflecting Psychology) against traditional care. This advances Psychedelics and Drug Studies.
Abstract
The pharmacological treatment of depression consists of taking antidepressant drugs for prolonged periods; its modest therapeutic effect can often be associated with significant adverse effects, while its discontinuation can lead to relapses. Psilocybin is today a novel and breakthrough therapy for major depression. It is a natural alkaloid in Psilocybe mushrooms, which are endemic to Mexico. Research on a larger scale is lacking in various populations, including the Mexican people. This proposal contemplates the experimental design of a preclinical (toxicity and pharmacological evaluation of an extract in mice) and clinical study by including the chemical analysis of a species of Psilocybe cubensis mushroom to characterize its main constituents. The clinical study will consider the safety evaluation by exploring tolerated doses of Psilocybe cubensis by measuring pharmacokinetic parameters after oral administration in healthy adults and an open trial on a sample of patients with major depressive disorder to assess the safety and efficacy of fully characterized Psilocybe cubensis in a two-single doses treatment, (with assisted psychotherapy), compared with the traditional care model at the Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz in Mexico City. This report presents the design of a research project with preclinical and clinical experimental components.